Events

Field Safety Notices about Dimension Vista® System

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Siemens Healthcare Diagnostics Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Siemens healthcare diagnostics has confirmed that dimension vista® calcium (ca) flex® reagent cartridge lot 16060bb may produce erroneously low results from specific well sets. this issue occurs infrequently, affecting less than 1 per 350 wells (< 0.3%). if calibration is performed using an unaffected well set and samples are subsequently run using an affected well set, ca results may be falsely depressed up to -2.9 mg/dl [-0.72 mmol/l]. if qc is run using an affected well set, qc may detect the issue. the bias observed from customer data for this scenario is shown in table 2. bias for serum, plasma and urine specimens are similar. .

Device

Dimension Vista® System

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS